PROFESSIONAL DEVELOPMENT AREA CREDITSTraining and/or education related to the biomedical/healthcare sector; scien-tific, clinical or engineering disciplines; business; law or other fields. This in-cludes sessions pertaining to the individual’s primary technical/scientific field, general business/management, or other disciplines or topics not specifically focused on regulatory or regulatory-related issues.

1 credit per hour3 credits per half day6 credits per day12 credits maximum per multiday event

University courses related to the scope of practice of regulatory professionals. This may include coursework related to business management. Courses must be full quarter or semester courses.

15 credits per semester; 10 credits per quarter with maximum of 30 credits per year

Additional Professional Credentials Earned

Additional RAC credentials earned. Successful attainment of an additional RAC credential must occur during the three-year certification period.

If a candidate passes an additional RAC, the cycle is updated, and candidates will have three years to recertify from the date of the most recently passed RAC exam.

Other relevant professional credentials earned (e.g., quality, clinical research, project management). Successful attainment of an additional credential mustoccur during the three-year certification period.

5 credits per credential

Course Organizer, Faculty, Speaker

Faculty, instructor or speaker at a training or educational program, course or RAC study group directly related to the scope of practice of a regulatoryprofessional requiring preparation of course materials or handouts in additionto presentation. Subject matter may include business and managementfunctions.

4 credits per hour of instruction

Faculty or instructor at a regulatory-related course offered by an accredited university or college, requiring lecture and preparation of course materials. Presentations that are repeated may not be included unless content has beenrevised.

4 credits per hour of instruction16 credits maximum per course

Panel member or respondent on regulatory topics and issues panel not requiring preparation of course materials or handouts.

2 credits per hour of presentation

Member of organizing or planning committee for a regulatory or regulatory- related training and/or educational program, course or conference track orsession. Additional credits can be earned for speaking at this event (see abovefor speaker credits). Presentations should be noted separately from role asorganizer.

2 credits per program, course

Instructor or speaker on regulatory-related presentations or training programswithin your organization. If presentations are offered on a single topicthroughout a year, list topic and total presentations for the year. This does notinclude presentations completed about company-specific information which ispart of one’s paid position.

4 credits per hour of instruction

Articles, Books and Other Published Content(May include materials published in print and/or electronic format.)

An article and/or chapter about regulatory-related topics, issues or advances published in a newsletter, magazine, journal, book, or as a monograph or booklet.

5 credits per article

Author of a book addressing issues/topics relevant to the regulatory profession.

Based on length and topic; maximum of 15 credits

Editor, member of editorial or peer-review board of journal, magazine or bookrelated to the regulatory profession requiring publication planning, authormanagement and review.

5 credits per publication

Brief editorial or column (less than one printed page) and/or Letter to the Editor related to regulatory issues and published in a professional publication.

1 credit each

Internet website developer, manager or editor for sites related to regulatoryprofession.

Credits determined on review by RACB

Leadership in Relevant Professional and Trade Organizations

Officer or board member. 2 credits per year of service

Committee or section chairman. 2 credits per year of service

Member of a committee, task force, council or other appointed group1. 1 credit per year of service

Regulatory Affairs Certification Recertification Guide 2